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Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter
One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB). The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously. The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.
Age
18 - 60 years
Sex
FEMALE
Healthy Volunteers
No
Emek medical center
Afula, Israel
Start Date
April 6, 2025
Primary Completion Date
January 29, 2027
Completion Date
January 29, 2027
Last Updated
December 1, 2025
140
ESTIMATED participants
Dinoprostone vaginal insert
DRUG
Dinoprostone gel and Foley catheter balloon
COMBINATION_PRODUCT
Lead Sponsor
HaEmek Medical Center, Israel
NCT07317674
NCT02477085
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07010653